DURATOCIN Solution for injection Ref.[27961] Active ingredients: Carbetocin

Source: Health Products and Food Branch (CA)  Revision Year: 2018 

Indications and clinical use

DURATOCIN (carbetocin injection) is indicated for the prevention of uterine atony and postpartum hemorrhage following cesarean section under epidural or spinal anaesthesia.

DURATOCIN has not been studied in cases involving patients with a history of hypertension, known coagulopathy or evidence of liver, renal or endocrine disease. Appropriate studies have not been undertaken and doses have not been established in women following labour or vaginal delivery.

Geriatrics (>65 years of age): Not recommended for use.

Pediatrics (<18 years of age): Not recommended for use.

Dosage and administration

A single intravenous dose of 100 mcg (1 mL) of DURATOCIN (carbetocin injection) is administered by bolus injection, slowly over 1 minute, only when delivery of the infant has been completed by cesarean section under epidural or spinal anesthesia. DURATOCIN can be administered either before or after delivery of the placenta.

Overdosage

Overdosage of carbetocin can be expected to produce enhanced pharmacological effects. Therefore, when carbetocin is administered postpartum, overdosage may be associated with uterine hyperactivity and pain. Symptoms of uterine hyperactivity include; uterine hypertonus, abdominal pain, discomfort associated with too frequent or too strong uterine contractions.

Overdosage of oxytocin may lead to hyponatraemia and water intoxication in severe cases, especially when associated with excessive concomitant fluid intake. Symptoms of water intoxication include;

  1. headache, anorexia, nausea, vomiting and abdominal pain
  2. Lethargy, drowsiness, unconsciousness and grand-mal type seizures

As carbetocin is an analogue of oxytocin, the possibility of a similar event cannot be excluded.

Treatment consists of symptomatic and supportive management.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Storage and stability

Store at room temperature (15°C to 30°C).

Once the vial has been opened, the product should be used immediately

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